Device recall
Z-1130-2018: Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate…
FDA device recall · Class II · Covidien LLC
Key facts
| Recall number (Z-number) | Z-1130-2018 |
|---|---|
| Recall event | 79296 |
| Product | Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate premium cotton are single use cotton disposable that must be used with the Situate delivery system. The disposable have an attached RF Tag, which is an electrically passive inductor like device that is sewn into the green… |
| Product code | GDY |
| Recalling firm | Covidien LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 12, 2020 |
| FEI number | 1219930 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database